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Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis (CHAMPIONS10)

This study has been completed.
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
R. Philip Kinkel, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00179478
First received: September 12, 2005
Last updated: August 6, 2017
Last verified: August 2017
  Purpose
The current study is a continuation of the 5 year extension study of the phase III CHAMPS study (see reference). This study was designed to determine if immediate initiation of therapy with Interferon Beta-1a (AVONEX) after a first attack of multiple sclerosis (MS) continues to delay the development of further attacks (CDMS) and the development of neurological disability over a 10 year period of observation. The initial 5 year extension study, called CHAMPIONS5, reported that immediate initiation of interferon Beta-1a (AVONEX) after a first attack of MS continued to delay the development of CDMS and lowered relapse rates compared to delayed initiation of disease modifying treatment (usually with AVONEX) either at the time of a second attack or at the end of the phase III study (24 months). The study was extended to 10 years to determine if these effects are sustained and result in less long term permanent disability.

Condition Intervention Phase
Multiple Sclerosis Optic Neuritis Transverse Myelitis Acute Brainstem/Cerebellar Syndrome Drug: interferon beta 1a 30 ug IM once weekly Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Open label study: The outcome committee determined the primary outcome event (the development of Clinically definite MS) without knowledge of original treatment assignment and the central MRI reading center was not aware of original treatment assignments
Primary Purpose: Treatment
Official Title: Controlled High-risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance (CHAMPIONS10)

Resource links provided by NLM:


Further study details as provided by R. Philip Kinkel, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Rate of Development of Clinical Definite Multiple Sclerosis (CDMS) Over 10 Years [ Time Frame: 10 years ]
    Percent cumulative probability of developing CDMS over 10 years . CDMS was defined as the development of new visual or neurological symptoms discrete from the patients initial event with objective findings on examination.


Secondary Outcome Measures:
  • Annualized Relapse Rate [ Time Frame: 10 years ]
    annualized # of relapses between years 0 and 10

  • Number of Participants With an EDSS > 3.5 at Study Completion [ Time Frame: 10 years ]
    The EDSS is an ordinal scale of neurological impairment in Multiple Sclerosis with a range of 0 to 10 with 0.5 increments. A score of 0 is normal and 10 is death from MS. Scores from 1 to 3.5 are considered mild impairment , 4.0 to 6.5 is moderate and greater than 6.5 is severe impairment.

  • The Number of New or Enlarging MRI T2 Lesions at 10 Years [ Time Frame: 10 years ]
    These are counts of new or significantly enlarged lesions over 10 years on brain MRI reflecting interval radiographic disease activity


Enrollment: 155
Study Start Date: February 2001
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate Treatment Group
Initiation of treatment with Interferon Beta 1a IM once weekly immediately after onset of a first demyelinating syndrome in high risk individuals
Drug: interferon beta 1a 30 ug IM once weekly
Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.
Active Comparator: Delayed Treatment Group
Delayed initiation of of Interferon beta-1a IM once weekly at diagnosis of clinically definite MS, at conclusion of initial CHAMPS study or during long term observation
Drug: interferon beta 1a 30 ug IM once weekly
Immediate treatment group refers to those patients who were randomized to the interferon beta 1a 30 ug IM once weekly treatment arm of the original, controlled phase III CHAMPS study; Delayed treatment group refers to those patients who were randomized to the placebo group during the original controlled, phase III CHAMPS study and did not start treatment, if at all, until they completed the CHAMPS study protocol at a later date.

Detailed Description:

The CHAMPS study determined that immediate initiation of interferon beta 1a therapy (AVONEX) immediately following a first clinical demyelinating event in high risk patients (i.e. those with at least 2 asymptomatic white matter lesions on cranial MR imaging > 3 mm in diameter or ovoid) delayed the development of clinical definite Multiple Sclerosis (CDMS)(as defined by a second, clinically verifiable attack involving another part of the central nervous system) over 2 years of observation and significantly decreased the development of new or enlarging white matter lesions on MRI over 18 months (see reference). The current study is a long term extension of a cohort of CHAMPS study site and participants. The three main aims of the study are as follows:

  1. To determine the long term neurological outcome in patients treated with interferon beta 1a (AVONEX) from onset of a first clinical demyelinating event
  2. To determine if immediate initiation of AVONEX therapy (the CHAMPS Avonex treatment group) confers long term benefits compared to delayed initiation of therapy (the CHAMPS placebo group) on the rate of development of CDMS, annualized relapse rates, the development of permanent disability and MR measures of disease activity and progression.
  3. To determine predictors of long term disease activity and disability in patients following a first clinical demyelinating event
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous participation in CHAMPS study
  • Participation in a study site willing to participate in the CHAMPIONS10 extension study
  • Willingness to enroll in the CHAMPIONS 10 extension
  • Willingness to sign informed consent

Exclusion Criteria:

  • Discovery of an alternative neurological disorder other than MS as a cause of initial neurological symptoms
  • A severe systemic disease with likely mortality within 3 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179478

  Show 26 Study Locations
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Biogen
Investigators
Principal Investigator: Revere P Kinkel, MD Beth Israel Deaconess Medical Center
  More Information

Publications:

Responsible Party: R. Philip Kinkel, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00179478     History of Changes
Other Study ID Numbers: 2003P000086
C-850 Extension study ( Other Identifier: Biogen Inc )
Study First Received: September 12, 2005
Results First Received: April 14, 2017
Last Updated: August 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by R. Philip Kinkel, Beth Israel Deaconess Medical Center:
Multiple sclerosis
Interferon Beta
MRI
Optic neuritis
Transverse Myelitis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Neuritis
Optic Neuritis
Myelitis
Myelitis, Transverse
Cerebellar Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Neurodegenerative Diseases
Brain Diseases
Interferons

ClinicalTrials.gov processed this record on September 19, 2017